Intravitreal Ranibizumab 0.5MG, or 1.0mg for RVO With Macular Edema Previously Receiving Bevacizumab

NCT01471691 | Completed Phase 1 Results

• 1 other identifier: ML27847
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 4

Brief Summary

This study examines two doses of Ranibizumab (0.5mg and 1.0mg) for the treatment of macular edema secondary to retinal vein occlusion in patients that have previously failed treatment with other macular edema treatments including bevacizumab.

Conditions

Branch Retinal Vein Occlusion; Central Retinal Vein Occlusion; Macular Edema

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline BCVA

  Vision was measured using a standard ETDRS chart at baseline and each subsequent monthly visit.

  Baseline to month 6

Secondary Outcomes (5)

• Mean Change From Baseline in Center Point Thickness

  months 1-12

• Change in Mean Best Corrected Visual Acuity From Baseline

  months 1-12

• Percentage of Patients With CFT Less Than 300um

  Month 6 and 12

• Excess Foveal Thickness

  Month 6 and 12

• Total Number of Ranibizumab Injections

  month 12

Study Arms (2)

intravitreal ranibizumab 0.5mg

EXPERIMENTAL

Drug: ranibizumab 0.5mg

intravitreal ranibizumab 1.0mg

EXPERIMENTAL

Drug: ranibizumab 1.0mg

Interventions

ranibizumab 0.5mg DRUG

Standard dose

Also known as: Lucentis

intravitreal ranibizumab 0.5mg

ranibizumab 1.0mg DRUG

High dose

Also known as: Lucentis

intravitreal ranibizumab 1.0mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study
• Age \> 18 years
• CRVO or BRVO diagnosis
• For CRVO, clinical evidence of perfused central retinal vein occlusion. A CRVO is defined as an eye that has retinal hemorrhages and a dilated retinal venous system in all 4 quadrants. Other evidence of a CRVO may include telangiectatic capillary bed and collateral vessels at the optic nerve head.
• Central macular edema present on clinical examination and OCT testing with a central point thickness and/or central 1mm subfield thickness \> 300 microns after at least 3 months of bevacizumab or steroid therapy.
• Visual acuity score greater than or equal to 19 letters (20/400) and less than or equal to 73 letters (20/40) by the ETDRS visual acuity protocol.
• Patients must demonstrate that they are no longer improving on bevacizumab or intravitreal steroid therapy (i.e. no improvement in acuity in 2 consecutive visits)
• BRVO patients treated with grid laser must show residual edema three months following latest laser treatment
• Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography

You may not qualify if:

• Pregnancy (positive pregnancy test) or known to be pregnant; also pre-menopausal women not using adequate contraception.
• Participation in another ocular investigation or trial simultaneously
• Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g. chronic alcoholism, drug abuse)
• Significant diabetic retinopathy (greater than moderate NPDR) or macular edema associated with diabetic retinopathy
• An eye that, in the investigator's opinion, has no chance of improving in visual acuity following resolution of macular edema (e.g. presence of subretinal fibrosis or geographic atrophy or severe epiretinal membrane)
• Presence of another ocular condition that may affect the visual acuity or macular edema during the course of the study (e.g. AMD, uveitis, Irvine-Gas)
• Evidence of neovascularization of the iris or retina (presence of ischemic CRVO/BRVO)
• Evidence of central atrophy or fibrosis in the study eye
• Presence of substantial cataract, one that might decrease the vision by 3 or more lines of vision at sometime during the study.
• History of grid/focal laser or panretinal laser in the study eye in the previous three months
• History of vitreous surgery in the study eye
• History of use of intravitreal, peribulbar, or retrobulbar steroids within three months of the study.
• History of cataract surgery within 6 months of enrollment.
• History of YAG capsulotomy within 2 months of the surgery.
• Visual acuity \<20/400 in the fellow eye

Sponsors & Collaborators

• Hanscom, Thomas, M.D.: lead
• Genentech, Inc.: collaborator

Study Sites (4)

South Coast Retina

Huntington Beach, California, 92647, United States

Location

South Coast Retina

Long Beach, California, 90807, United States

Location

Thomas Hanscom AMC

Santa Monica, California, 90404, United States

Location

South Coast Retina

Torrance, California, 90505, United States

Location

MeSH Terms

Conditions

Retinal Vein Occlusion; Macular Edema

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Macular Degeneration; Retinal Degeneration

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Thomas O'Hearn MD
• Organization: Thomas Hanscom AMC

tohearn@gmail.com

310-829-3303

Study Officials

• Thomas O'Hearn, MD

  Thomas Hanscom AMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: November 16, 2011
• Study Start: November 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 29, 2015
• Results First Posted: April 29, 2015

Record last verified: 2015-04

Locations

US (4)